Table 5.
Number (%) of subjects reporting AEIs and other AEs within 7 days post-dose 2 (i.e., vaccination day and following 6 days) using AERC in Spain
| MedDRA primary system organ class (CODE) | N = 139 | |
|---|---|---|
| Preferred term (code) | n | % |
| Any | 34 | 24.5 |
| Any respiratory, thoracic, and mediastinal disorders (10038738) | 21 | 15.1 |
| Cough (10011224)* | 12 | 8.6 |
| Rhinorrhea (10039101)* | 9 | 6.5 |
| Nasal congestion (10028735)* | 7 | 5.0 |
| Dysphonia (10013952)* | 3 | 2.2 |
| Wheezing (10047924)* | 2 | 1.4 |
| Epistaxis (10015090)* | 1 | 0.7 |
| Sneezing (10041232) | 1 | 0.7 |
| Oropharyngeal pain (10068319)* | 0 | 0.0 |
| Any general disorders and administration site conditions (10018065) | 11 | 7.9 |
| Injection site pain (10022086)* | 7 | 5.0 |
| Pyrexia (10037660)* | 6 | 4.3 |
| Chills (10008531)* | 0 | 0.0 |
| Face edema (10016029)* | 0 | 0.0 |
| Fatigue (10016256)* | 0 | 0.0 |
| Injection site erythema (10022061)* | 0 | 0.0 |
| Injection site swelling (10053425)* | 0 | 0.0 |
| Any infections and infestations (10021881) | 5 | 3.6 |
| Conjunctivitis (10010741)* | 4 | 2.9 |
| Rhinitis (10039083)* | 1 | 0.7 |
| Any gastrointestinal disorders (10017947) | 4 | 2.9 |
| Diarrhea (10012735)* | 2 | 1.4 |
| Vomiting (10047700)* | 1 | 0.7 |
| Abdominal pain (10000081) | 1 | 0.7 |
| Nausea (10028813)* | 0 | 0.0 |
| Any metabolism and nutrition disorders (10027433) | 4 | 2.9 |
| Decreased appetite (10061428)* | 4 | 2.9 |
| Any psychiatric disorders (10037175) | 4 | 2.9 |
| Irritability (10022998)* | 4 | 2.9 |
| Any eye disorders (10015919) | 2 | 1.4 |
| Eye pruritus (10052140) | 2 | 1.4 |
| Any musculoskeletal and connective tissue disorders (10028395) | 1 | 0.7 |
| Myalgia (10028411)* | 1 | 0.7 |
| Arthropathy (10003285)* | 0 | 0.0 |
| Any skin and subcutaneous tissue disorders (10040785) | 1 | 0.7 |
| Rash (10037844)* | 1 | 0.7 |
| Rash generalized (10037858)* | 0 | 0.0 |
| Any immune system disorders (10021428) | 0 | 0.0 |
| Anaphylactic reaction (10002198)* | 0 | 0.0 |
| Hypersensitivity (10020751)* | 0 | 0.0 |
| Any nervous system disorders (10029205) | 0 | 0.0 |
| Febrile convulsion (10016284)* | 0 | 0.0 |
| Headache (10019211)* | 0 | 0.0 |
AE adverse event, AEI adverse event of interest, AERC adverse event reporting card, MedDRA Medical Dictionary for Regulatory Activities [11], N total number of subjects, n number of subjects in category
*AEI